MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA PK CMT TIB LM SZ H; PROSTHESIS, KNEE

Catalog Number	42538000801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 42558000701 persona pk cmt fem lm sz 7 lot# 66246999, 42538000801 persona pk cmt tib lm sz h lot# 66120846, 42518200808 persona pk ve ply lm sz h 8mm lot# 66281837.G2: australia customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded by the facility.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent knee revision surgery from a unicompartmental knee arthroplasty to a total knee arthroplasty one year, two months post implantation.Patient reported anterior knee pain although x-ray and mri noted no abnormalities.The surgeon noted anterior knee pain being consistent with quad wasting/patella instability secondary to weakness.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h2; h4, h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.These notes confirmed the event allegations of anterior pain.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Complaint was confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA PK CMT TIB LM SZ H
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23457354
• Report Number: 0001825034-2025-03443
• Device Sequence Number: 7875546
• Product Code: HSX
• UDI-Device Identifier: 00880304812741
• UDI-Public: (01)00880304812741(17)330611(10)66120846
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 42538000801
• Device Lot Number: 66120846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male